If you wish to respond to a paper or other item already published in the BJA, please go to the abstract/full text version of that item and click on the link "E-Letters: Submit a response to the article".
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E-letters: Electronic letters published:
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evaluating reference accuracy may be controversial
- Alain Rochette (2 December 2008)
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Reference accuracy
- Michael G Irwin (16 November 2008)
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In response
- Alain Rochette, Xavier Capdevila (15 September 2008)
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"Pain on propofol injection, some tips"
- Prasad K Narasimha (11 September 2008)
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Ethics is everyone's business
- Gordon B Drummond (5 September 2008)
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Injection pain due to propofol in children and the ethics of placebo
- Neil S. Morton (31 August 2008)
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Alain Rochette
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Sir, The comment by M. G. Irwing reveals how carefully the references must be considered. We mentioned propofol injection pain as the 3rd most important clinical outcome to avoid, according to the paper by Macario et al. Irwing contests this statement and argues that Macario et al "ranked propofol injection pain as number 30 in importance to avoid". In fact, Macario et al established a 1st list scoring frequency of adverse outcomes where propofol injection pain ranks 3rd. Another list scores adverse outcomes for importance to avoid from a patient's viewpoint as perceived by experts. Unsurprisingly, the 2nd list starts with "death" and permanent injuries and ranks propofol injection pain in position 30. Finally, the authors established a combined final ranking according to the aim of the paper: contribute to identify next stops in quality improvement in anaesthesia: avoiding propofol injection pain ranks 3rd in frequency and 4th in importance to avoid in this final list. We fully agree with this approach to improve quality in anaesthesia, especially in paediatric patients. In the same approach, we thank Dr P. K. Narashimba for his personal contribution to limit propofol injection pain. Unfortunately, some of his suggestions (like large bore IV access) cannot easily be used in young children. Conflict of Interest:None declared |
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Michael G Irwin, Head Dept of Anaesthesiology, University of Hong Kong
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Dear Sir, The above paper states in the discussion section that "Pain on propofol injection has been classified by a panel of expert anaesthetists as the third most important clinical outcome to avoid in adult anaesthesia" and cites Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg 1999; 88: 1085–91. The cited paper, however, found that propofol injection pain ranked as number 30 in importance to avoid according to their experts' final ranking of clinical anesthesia outcomes - quite a difference! The process of manuscript review has already been called into question in correspondence to the journal in relation to this paper. It is a laborious but important process, however, such glaring errors should not be overlooked. Conflict of Interest:None declared |
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Alain Rochette , Xavier Capdevila
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Sir, We appreciate the comments from Dr Morton and Dr Drummond and fully agree with the claim that the best interests of trial subjects must be protected. Dr Morton argues that lidocaine, 0.2 mg/kg, mixed with propofol provides painless injection in all children and therefore should be the gold standard given to the control group. Not everybody agrees with this statement and several alternative treatments have been tested since lidocaine, even in larger doses, fails to eliminate injection pain in 24 to 39 % of patients, as discussed in our paper and confirmed in our results. Such controversial data prompted us to refer to the methods of evidence based medicine, and include a placebo-control group. This is recommended through the Best Pharmaceutical for Children Act, the FDA requests, the European Union Directive 2001/20/EC or the guidelines of the American Academy of Pediatrics when a reference treatment is not effective enough to be unquestionable. The ethical acceptability of this choice was discussed when the design of the study was developed. A bibliographic research on ethical considerations in paediatric clinical trials over 10 years was not very helpful: most of the papers were editorial views pointing out aspects of the dilemma but few practical guidelines were available, especially addressing the use of placebo (1). However, all authors deeply regret that children still remain “therapeutic orphans”. In the particular field of injection pain, an uncomfortable but brief and not dangerous condition, it must be considered that the lack of data usually leads to give up preventing injection pain or, more often, to choose inhalation anaesthesia. This choice is not necessarily the best care, as induction of inhalation anaesthesia is not always smooth and may lead to emergence delirium, both uncomfortable conditions that last for much longer than injection pain and occasionally can lead to persistent “fear of mask”. In our experience as well as in this study, few patients experienced major discomfort (>4/6 in our scale): 7 out of 38 in the control group, 2/41, 2/39 and 0/39 in treatment groups. None complained about that thereafter. Considering all sides of the problem, the design of our study was accepted and the parents were clearly informed of all aspects of the study. (1) Anderson B, Cranswick N. The placebo (I shall please) - is it so pleasing in children? Pediatr Anesth 2005; 15: 809-13. Conflict of Interest:None declared |
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Prasad K Narasimha, Asst professor Kasturba Medical College, Manipal
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Pain at the site of injection during induction with propofol is a known fact and addition of lidocaine has been a routine practice. With the availability of mct- propofol emulsion, the pain has definitely come down as observed in our clinical practice. We have also observed that the pain has nearly never been complained when lidocaine is added to this new preparation. Another practice which we follow is that the first 1mg/ kg of propofol- lidocaine mixture is administered as a dilute solution of 0.2- 0.5 % slowly over 30 seconds followed by the rest of the induction dose as a 1 % solution. Administration of 1 microgram/ kg of fentanyl before induction, use of a large bore IV access definitely reduces the incidence of pain. Conflict of Interest:None declared |
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Gordon B Drummond
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Dr Morton makes an important point, but I suggest it goes further. Ethics review committees do not have the only word on this matter, nor are they infallible. If an article gets into print, several people who can affect the process should have read and judged the content, and I suggest all should have considered the ethical aspect of the study. Having experienced the discomfort of propofol without lidocaine, I would think twice about consenting to a study such as this. I would be very interested to know if the consent form provided information to the parents about the likelihood of discomfort to the participants. If not, I suspect that the committee has not been vigilant concerning the interests of the subjects. In addition, the paper must have been read by referees and an editor: each is entitled to object to the ethics of a study, irrespective of the stated approval by an ethics committee. In fact I would argue that each is OBLIGED to object if they think that the study they are considering is unethical. I read many papers to consider the ethics of animal studies: and always bear in mind the editorial titled "The benefit of the doubt goes to the animal". Here the benefit of the doubt should surely go to the children? Ethics committees are thought of by many as a nuisance: and they can indeed be wrong. They, as do we all, have a duty to get it right. When they do, they are a valuable and important part of the research process. Drummond JC, Todd MM, Saidman LJ. Use of neuromuscular blocking drugs in scientific investigations involving animal subjects: The benefit of the doubt goes to the animal. Anesthesiology 1996; 85: 697-9. Conflict of Interest:I am senior ethics editor for the Journal of Physiology |
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Neil S. Morton
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Sir, I was interested in this study of reducing injection pain due to propofol in children, which is a laudable aim. However, I question the ethics of a placebo-controlled trial design in children below age 7 years in the light of current guidance and the tenets of the Declaration of Helsinki which seeks to protect the best interests of trial subjects. In particular to have one quarter of the trial subjects exposed to lct-propofol with no added lignocaine as one of the control arms seems to me to be completely unacceptable. Indeed, this was so in 1992 when we discussed such a study with our ethics committee and agreed that to deny a control group the most efficacious known treatment was unethical (Anaesthesia 1992 47:604-6) and therefore adopted a step-down technique to establish the minimum effective dose of lignocaine for this purpose, namely 0.2mg/kg. Thus the authors of this paper have not only denied analgesia to a control population but have also exposed trial subjects to more than twice the effective dose of lignocaine, 0.5mg/kg. It was also interesting that they had to adjust their power calculations and numbers of study subjects and although they do not say so, I suspect this was because of unacceptable pain experiences of their child patients. I fully appreciate the difficulties of conducting paediatric research but I was surprised that such a trial design achieved IRB approval and survived the peer review process of a major international journal. I think researchers, editors, reviewers and ethics committees need to be more aware of modern paediatric ethics standards in order to protect the best interests of both trial subjects and control groups. Conflict of Interest:I am the Editor-in-Chief of the journal Pediatric Anesthesia |
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